53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details
臨床試験数 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-000400-26-GB (EUCTR) | 17/03/2017 | 14/12/2016 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 2 | NCT02631538 (ClinicalTrials.gov) | February 17, 2016 | 14/12/2015 | Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome | A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome | Sjogren's Syndrome | Drug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximab | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 86 | Phase 2 | Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom |
| 3 | EUCTR2015-000400-26-IT (EUCTR) | 18/01/2016 | 10/11/2020 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: MABTHERA Product Code: [NA] INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO Product Name: BENLYSTA Product Code: [na] INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: SOLU-MEDROL Product Code: [na] INN or Proposed INN: METILPREDNISOLONE Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [na] INN or Proposed INN: PARACETAMOLO Trade Name: XYZAL - 20 COMPRESSE RI | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2015-000400-26-NO (EUCTR) | 08/01/2016 | 23/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2015-000400-26-NL (EUCTR) | 28/12/2015 | 08/12/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2015-000400-26-SE (EUCTR) | 15/12/2015 | 08/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2015-000400-26-DE (EUCTR) | 03/12/2015 | 01/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2015-000400-26-FR (EUCTR) | 01/12/2015 | 24/02/2017 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway | ||
| 9 | EUCTR2015-000400-26-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 10 | NCT01160666 (ClinicalTrials.gov) | March 2010 | 9/7/2010 | Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome | A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's Syndrome | Sjögren's Syndrome | Drug: Belimumab | Assistance Publique - Hôpitaux de Paris | Human Genome Sciences Inc. | Completed | 18 Years | N/A | Both | 20 | Phase 2 | France |
| 11 | EUCTR2009-015978-35-FR (EUCTR) | 30/11/2009 | 01/10/2009 | Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISS | Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISS | Syndrome Sjogren's MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's | Product Name: HGS1006, LymphoStat-B INN or Proposed INN: belimumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | France | ||
| 12 | NCT01008982 (ClinicalTrials.gov) | August 2009 | 5/11/2009 | Efficacy and Safety of Belimumab in Primary Sjögren's Syndrome | A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Primary Sjögren's Syndrome. | Sjögren's Syndrome | Drug: LimphoStat-B | University of Udine | Azienda Ospedaliera S. Maria della Misericordia | Completed | 18 Years | 90 Years | Both | 15 | Phase 2 | Italy |